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Tigecycline, sold under the brand name Tygacil, is a tetracycline antibiotic medication for a number of bacterial infections. [ 3 ] [ 6 ] [ 7 ] It is a glycylcycline class drug that is administered intravenously.
Glycylcycline antibiotics have a similar mechanism of action as tetracycline antibiotics. They block protein synthesis hence preventing bacterial reproduction. Both classes of antibiotics bind to the 30S ribosomal subunit to prevent the amino-acyl tRNA from binding to the A site of the ribosome.
The MedWatch system collects reports of adverse reactions and quality problems of drugs and medical devices but also for other FDA-regulated products (such as dietary supplements, cosmetics, medical foods, and infant formulas). As of the summer of 2011, the program had received more than 40,000 adverse event reports. [1]
In combination with palbociclib and fulvestrant for the treatment of adults with endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth-factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, as detected by an FDA-approved test, following recurrence on or after completing adjuvant ...
Academic users can apply for a free license for certain use cases while all other users require a paid license. The latest release of the database (version 5.0) contains 9591 drug entries including 2037 FDA -approved small molecule drugs, 241 FDA-approved biotech ( protein / peptide ) drugs, 96 nutraceuticals and over 6000 experimental drugs ...
application, FDA may furnish the summary to FDA advisory committee members and agency officials whose duties require an understanding of the application. To the extent possible, data in the summary should be presented in tabular and graphic forms. FDA has prepared a guideline
Therapeutic equivalence evaluations in this publication are not official FDA actions affecting the legal status of products under the Act. Finally, the Orange Book lists patents that are purported to protect each drug. Patent listings and use codes are provided by the drug application owner, and the FDA is obliged to list them.
DailyMed is a website operated by the U.S. National Library of Medicine (NLM) to publish up-to-date and accurate drug labels (also called a "package insert") to health care providers and the general public.